BACKGROUND: Exercise is one of the most common triggers of bronchoconstriction and affects up to 80% of children with asthma. OBJECTIVE: The purpose of this randomized, double-blind, placebo-controlled study was to assess the effectiveness of treatment with ciclesonide 160 microgram, either alone, with a higher dose, with a leukotriene receptor antagonist (LTRA), or with a long-acting beta-agonist (LABA) in children with asthma with postexercise-induced symptoms. METHODS:Eighty adolescents, ages 1218 years, with asthma and postexercise symptoms were enrolled. Children were treated in one of four treatment groups: ciclesonide 160 microgram daily dose (cic 160), ciclesonide 320 microgram daily dose (cic 320), ciclesonide 160 microgram daily dose combined with montelukast (cic + LTRA), or ciclesonide 160 microgram daily combined with formoterol (cic + LABA). The impact of treatment on clinical symptoms, maximum percentage decrease in forced expiratory volume in 1 second after intense exercise effort, fractional exhaled nitric oxide in exhaled breath, and the contribution of inflammatory mediators in exhaled breath condensate were assessed. RESULTS: In children with asthma and with postexercise symptoms, 8-week daily administration of ciclesonide 320 microgram, ciclesonide 160 microgram plus LABA, and ciclesonide 160 microgram alone decreased daytime symptoms; decrease in maximal fall in forced expiratory volume in 1 second reached the level of significance in the cic 320, cic + LABA, and cic + LTRA groups. A higher prevalence of positive responses to treatment after addition of an LTRA or LABA to ciclesonide 160 microgram for patients with exercise treadmill challengeinduced clinical symptoms only was revealed. CONCLUSION: Monotherapy with ciclesonide 320 microgram can be as effective as combined therapy in reducing exercise-induced bronchoconstriction. We revealed a higher prevalence of positive responses to treatment after the addition of LTRA or LABA to ciclesonide 160 microgram for patients with exercise treadmill challengeinduced clinical symptoms only. ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov"www.ClinicalTrials.gov/ext-link NCT01798823.
RCT Entities:
BACKGROUND: Exercise is one of the most common triggers of bronchoconstriction and affects up to 80% of children with asthma. OBJECTIVE: The purpose of this randomized, double-blind, placebo-controlled study was to assess the effectiveness of treatment with ciclesonide 160 microgram, either alone, with a higher dose, with a leukotriene receptor antagonist (LTRA), or with a long-acting beta-agonist (LABA) in children with asthma with postexercise-induced symptoms. METHODS: Eighty adolescents, ages 1218 years, with asthma and postexercise symptoms were enrolled. Children were treated in one of four treatment groups: ciclesonide 160 microgram daily dose (cic 160), ciclesonide 320 microgram daily dose (cic 320), ciclesonide 160 microgram daily dose combined with montelukast (cic + LTRA), or ciclesonide 160 microgram daily combined with formoterol (cic + LABA). The impact of treatment on clinical symptoms, maximum percentage decrease in forced expiratory volume in 1 second after intense exercise effort, fractional exhaled nitric oxide in exhaled breath, and the contribution of inflammatory mediators in exhaled breath condensate were assessed. RESULTS: In children with asthma and with postexercise symptoms, 8-week daily administration of ciclesonide 320 microgram, ciclesonide 160 microgram plus LABA, and ciclesonide 160 microgram alone decreased daytime symptoms; decrease in maximal fall in forced expiratory volume in 1 second reached the level of significance in the cic 320, cic + LABA, and cic + LTRA groups. A higher prevalence of positive responses to treatment after addition of an LTRA or LABA to ciclesonide 160 microgram for patients with exercise treadmill challengeinduced clinical symptoms only was revealed. CONCLUSION: Monotherapy with ciclesonide 320 microgram can be as effective as combined therapy in reducing exercise-induced bronchoconstriction. We revealed a higher prevalence of positive responses to treatment after the addition of LTRA or LABA to ciclesonide 160 microgram for patients with exercise treadmill challengeinduced clinical symptoms only. ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov"www.ClinicalTrials.gov/ext-link NCT01798823.